BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Impotence, Mechanical/Hydraulic

    PMA: P000006 · Supplement: S029 · Decision Jan 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Impotence, Mechanical/Hydraulic
    Trade Name
    TITAN INFLATABLE PENILE PROSTHESIS
    PMA Number
    P000006
    Supplement Number
    S029
    Device Class
    FDA Class 3
    Product Code
    FHW
    Generic Name
    Device, impotence, mechanical/hydraulic
    Regulation Number
    876.3350
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 29, 2013
    Date Received
    December 14, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE TITAN NARROW BASECYLINDER (11 AND 14 CM LENGTHS ONLY): (I) CHANGE OF THE ANGLE OF THE TUBING FROM 22.5° TO 0°, AND (II) CHANGE IN CYLINDER TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FHW Device, Impotence, Mechanical/Hydraulic